MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-29 for INTERPHLEX 360-2810 manufactured by Osteomed.
[850343]
Pt had prior history of dislocated 2nd mpj. Pt received interphlex implant. At 2 days post op, pt was fine. Approx. 1 week later, it was determined that silicone rod had broken near ball. Device explanted. Pt is currently doing well. Review of dhr shows no anomalies. Based on info received, doctor handled device with blunt instruments as recommended in the labeling.
Patient Sequence No: 1, Text Type: D, B5
[8062403]
The returned rod was examined and pictures are included in file that show no signs implant was handled with sharp instruments. Pt's first visit post-op shows implant was fine. At next visit a week later, the implant was broken. Review of device history record shows no issues or events during mfr of product. According to rep, surgeon handled device with blunt instruments. This is a soft silicone elastomer that can be damaged with sharp instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2008-00008 |
| MDR Report Key | 1054094 |
| Report Source | 05 |
| Date Received | 2008-05-29 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-04-01 |
| Date Mfgr Received | 2008-05-02 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2008-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBECCA ELLIS |
| Manufacturer Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERPHLEX |
| Generic Name | FLEXIBLE STABILIZATION ROD, MPJ |
| Product Code | LZJ |
| Date Received | 2008-05-29 |
| Returned To Mfg | 2008-05-06 |
| Model Number | 360-2810 |
| Catalog Number | 360-2810 |
| Lot Number | 1014455 |
| Device Expiration Date | 2011-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1023503 |
| Manufacturer | OSTEOMED |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-29 |